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CHLORINATED PARAFFINS REGULATORY UPDATE

August 2003

The Chlorinated Paraffins Industry Association (CPIA) periodically prepares updates to inform processors and users of chlorinated paraffins of the latest regulatory developments. The following is an update on developments in the United States, Canada, Europe and the United Nations. All previous updates are available on the CPIA website at www.regnet.com/cpia. UNITED STATES There have been no new regulatory developments in the United States (US) since the mid-1990's. At that time, the US Environmental Protection Agency, after an extensive investigation, concluded that there was no need to impose any restrictions on the manufacture, processing or use of any chain length chlorinated paraffin (CP). The only specific federal environmental regulation is an annual requirement that requires certain facilities to report environmental releases of short-chain chlorinated paraffins (SCCPs) under the Toxic Release Inventory (TRI). Guidance on the reporting of SCCPs within the category of "polychlorinated alkanes (C10 to C13)" can be found at www.epa.gov/tri/guidance.htm. Chlorinated paraffins remain excluded from federal hazardous waste regulations. CPs in waste oils, however, must be managed as hazardous waste in the state of Washington. Cancer Classification of C12, 60% Chlorinated Paraffins In 1989, as a result of laboratory testing in animals, the average C12, 60% chlorine CP was listed as a suspect carcinogen in the National Toxicology Program's Fifth Annual Report on Carcinogens. This compound was also classified by the International Agency for Research on Cancer (IARC) as a Group 2B carcinogen. Based on this listing and classification, the OSHA Hazard Communication Standard requires a special cancer warning on the label of any product containing more than 0.1% of a C12, 60% Cl chlorinated paraffin. No such labeling is required for all other types of SCCPs or for any mid-chain or long-chain CPs. In the past few years, considerable effort has been devoted to understanding the significance to man of the cancers in the thyroids, livers and kidneys observed in the National Toxicology Program (NTP) rodent studies. It is well known that experimental animals of the type used by NTP have metabolic systems, which operate differently from those of humans; these animals frequently display adverse effects in the organs seen in the short-chain study which do not occur in people. In 1997, a Panel of Specialized Experts in the European Union (EU) reviewed the animal data on the short-chain material and concluded that the cancer in the thyroid and liver were not relevant for human risk assessment. Research to understand the kidney cancers seen in male rats continues. California Chlorinated paraffin "C12, 60% chlorine" has also been listed as a potential carcinogen under California's Proposition 65. A "no significant risk level" (NSRL) of 8 µg/day has been adopted. As a result, products that could result in exposures above the 8 µg/day NSRL are required to have appropriate warnings posted. No other CPs are currently listed, or are known to be under consideration for inclusion on the Proposition 65 list. EUROPEAN UNION Short-chain Chlorinated Paraffins The June 2002 Marketing and Use Directive relating to SCCPs came into force in January 2003 to address concerns relating to environmental release. Under the amended Marketing and Use Directive (76/679/EEC), SCCPs may not be marketed or used in concentrations greater than 1% for metalworking and leather finishing. EU member countries are required to adopt regulations to comply with the EU Directive by January 2004. Other uses such as paints, coatings and flame retardants are not affected. Mid-chain Chlorinated Paraffins A draft EU risk assessment for mid-chain chlorinated paraffins (MCCPs), prepared by the United Kingdom (UK), was posted on the European Chemical Bureau website in August of 2002. The draft assessment included a provisional recommendation that MCCPs be classified as dangerous for the environment because of concerns relating to toxicity to aquatic organisms. The CEFIC Chlorinated Paraffins Sector Group, which represents the European producers of chlorinated paraffins, is working with the UK and participating in the relevant EU Technical Meetings to promote a reasonable assessment. Additional testing of MCCPs is underway to provide necessary clarification of effects. Long-chain Chlorinated Paraffins Long-chain chlorinated paraffins (LCCPs) are not included on the EU priority list. The UK, however, issued a draft national environmental risk assessment for LCCPs in November 2002. The risk assessment concluded that the risk to surface water, waste water and the atmosphere from LCCPs with chain lengths greater than C20 (those typically manufactured in the US) was low. CPIA has volunteered to work with the UK on LCCPs under the International Council of Chemical Associations (ICCA) High Production Volume (HPV) Initiative. CANADA In 1993, Environment Canada classified SCCPs as "toxic" under the Canadian Environmental Protection Act (CEPA). MCCPs and LCCPs have not been classified as toxic under CEPA. Similar to the US TRI requirement, in 1999, Environment Canada added SCCPs to the list of chemicals subject to reporting pursuant to the Canadian National Pollutant Release Inventory (NPRI). Two CAS numbers were specified: Alkanes, C6 to C18, Chloro CAS# 68920-70-7; and Alkanes, C10 to C13, Chloro CAS# 85535-84-8. Only the quantity of an NPRI substance present at concentrations greater than 1% by weight, plus the quantity present as by-products at any concentration, need to be considered in the threshold calculation. Environment Canada is currently assessing the data gathered as a result of its November 2002 Reporting Rule for chlorinated paraffins. The rule required all Canadian companies that manufactured, imported, exported, distributed or sold chlorinated paraffins or products formulated with chlorinated paraffins in 2000 and/or 2001 to report information by February 2003. Environment Canada is continuing to assess whether SCCPs should be classified as "Track 1" under CEPA. UNITED NATIONS United Nations Economic Commission for Europe Protocol on Long Range Transboundary Atmospheric Transport Canada has been promoting SCCPs for consideration under the United Nations Economic Commission for Europe (UNECE) "Protocol on Long Range Transboundary Atmospheric Transport of Persistent Organic Pollutants." A draft dossier on SCCPs will be submitted by Canada to the UNECE Working Group in September 2003. CPIA continues to actively contest the data provided by Canada in its Dossier. UNEP The United Nations Environment Program (UNEP) has been addressing twelve Persistent Organic Pollutants (POPs) under the "Stockholm Convention." Over the past year, UNEP prepared Regional and Global reports on various Persistent Toxic Substances (PTS) to assist in its research and prioritization of activities. Initially, all CPs were included in the assessment; as a result of the intervention of CPIA and the European CP industry, the Global report now focuses just on an assessment of SCCPs. For additional information contact: Robert J. Fensterheim, Executive Director Chlorinated Paraffins Industry Association 1250 Connecticut Avenue, NW, Suite 700 Washington, DC 20036 Phone: (202) 637-9040 Fax: (202) 637-9178 E-mail: bobf@regnet.com www.regnet.com/cpia